On October 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre reported an exclusive commercialization agreement for tabelecleucel (tab-cel) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers (Press release, Atara Biotherapeutics, OCT 4, 2021, View Source [SID1234590749]). Atara will retain full rights to tab-cel in other major markets, including North America, Asia Pacific, and Latin America.
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Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre.
Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).
"Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships," commented Pascal Touchon, President and CEO of Atara. "Our Companies’ complementary capabilities will expand access to tab-cel, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers."
Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology.
"Tab-cel is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,’" said Eric Ducournau, CEO of Pierre Fabre. "We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients."
PJT Partners served as the exclusive financial advisor to Atara.
Atara Conference Call
In connection with this announcement, Atara will host a webcast and conference call today at 8:30 a.m. EDT. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13723585. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company’s website for 30 days.
About Tabelecleucel
Tabelecleucel (tab-cel) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.
Tab-cel is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.
Tab-cel has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel has orphan drug designation in the U.S. and EU.